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S.D. voters to decide ‘any willing provider’ question; other state initiatives highlighted
South Dakota voters’ decision on an “any willing provider” ballot initiative is among a number of health care–related ballot initiatives that will be voted on in the upcoming midterm elections.
Others include a measure in Illinois that would require insurance providers that have prescription drug coverage to provide prescription contraceptives, and an Arizona ballot question regarding terminally ill patients’ access to experimental drugs.
If approved, South Dakota’s Initiative Measure 17 would allow providers who are willing to meet a health insurer’s coverage terms to provide health care services to insured patients without those patients incurring any out-of-network fees.
In recent years, the state has seen a significant increase in the number of closed and narrow provider networks, noted Dr. Mary J. Milroy, president of the South Dakota State Medical Association. That has disrupted the patient-physician relationship as patients find their long-time physicians are no longer in their health plan’s networks, said Dr. Milroy, a general surgeon from Yankton, S.D.
“Most patients don’t automatically choose their insurance company,” Dr. Milroy said in an interview. Employers can change employees’ insurance coverage, or coverage could shift with an employment change.
“If your personal physician, who maybe has been taking care of you for years, is not included in the panel for the new plan, then you have to switch or you have to incur out-of-pocket costs,” she explained. “We do not think that is good for continued and comprehensive medical care.”
Under the ballot question, physicians not in a patient’s insurance network but who want to continue a relationship with that patient would simply have to agree to the terms that the insurance provider has for physicians in its network. There would be no special treatment and physicians would have to uphold any terms imposed on in-network providers, including agreeing to reimbursement rates, quality standards, and other terms. If they agree, the patient’s visit would be treated like an in-network visit.
“We don’t see that such a change would negatively affect cost of health care,” Dr. Milroy said. “In fact, we think it would actually increase competition.”
If voters agree and vote positively on the initiative, it will have the force of law, according to Dr. Milroy.
Illinois voters will be asked to vote yes or no on whether any insurance plan in the state that offers prescription drug coverage “be required to include prescription birth control as part of that coverage.”
How that is to be implemented and what exactly would be covered as part of prescription birth control would be determined when the state legislature crafted a bill following voters’ approval of the question, which would leave the question of whether emergency contraception would be covered.
Dr. Maura P. Quinlan, chair of the Illinois Section of the American Congress of Obstetricians and Gynecologists, said in an interview that the ballot initiative is a way for voters to weigh in on the debate, noting cases like the recent Hobby Lobby Supreme Court decision had “no role for voters in Illinois to say how they feel about this.”
In general, the Illinois section supports the ballot initiative, commenting that while there might be costs associated with coverage, “it is so much cheaper to cover the cost to prevent an unplanned pregnancy than to pay for the pregnancy, the care of the child, etc. Always, preventive measures are much cheaper when insurance is trying to decide what they cover,” said Dr. Quinlan, who is in private practice in La Grange, Ill.
In Illinois, the ballot question does not have the force of law but would require the state legislature to enact a law to implement the initiative.
In another ballot initiative, Arizona voters will be asked to decide whether terminal patients in the state should have access to experimental drugs that have not yet received FDA approval.
According to the text of the “Terminal Patients’ Right to Try” act, an eligible patient must have a terminal illness as determined by the person’s physician, and the physician has determined there is “no comparable or satisfactory” FDA-approved treatment option “available to diagnose, monitor, or treat the disease or condition involved and that the probable risk to the person from the investigational drug, biological product, or device is not greater than the probable risk from the disease or condition.”
Products in question need to have successfully undergone phase I study and remain under clinical investigation. Manufacturers would not be required to provide access to the investigational drug, and it would be up to the company as to whether it collects compensation for the product or requires data collection on the drug’s effects as part of providing access to the product.
Similarly, insurance companies would not be required to cover access to the investigational product.
The measure also provides protections for the physician, stating that a state regulatory authority cannot take action against a physician’s license “based solely on a physician’s recommendation to an eligible patient regarding or prescribing for or treatment with an investigational drug, biological product, or device.”
The language of the ballot measure passed the state House on March 4 and state Senate on April 15.
South Dakota voters’ decision on an “any willing provider” ballot initiative is among a number of health care–related ballot initiatives that will be voted on in the upcoming midterm elections.
Others include a measure in Illinois that would require insurance providers that have prescription drug coverage to provide prescription contraceptives, and an Arizona ballot question regarding terminally ill patients’ access to experimental drugs.
If approved, South Dakota’s Initiative Measure 17 would allow providers who are willing to meet a health insurer’s coverage terms to provide health care services to insured patients without those patients incurring any out-of-network fees.
In recent years, the state has seen a significant increase in the number of closed and narrow provider networks, noted Dr. Mary J. Milroy, president of the South Dakota State Medical Association. That has disrupted the patient-physician relationship as patients find their long-time physicians are no longer in their health plan’s networks, said Dr. Milroy, a general surgeon from Yankton, S.D.
“Most patients don’t automatically choose their insurance company,” Dr. Milroy said in an interview. Employers can change employees’ insurance coverage, or coverage could shift with an employment change.
“If your personal physician, who maybe has been taking care of you for years, is not included in the panel for the new plan, then you have to switch or you have to incur out-of-pocket costs,” she explained. “We do not think that is good for continued and comprehensive medical care.”
Under the ballot question, physicians not in a patient’s insurance network but who want to continue a relationship with that patient would simply have to agree to the terms that the insurance provider has for physicians in its network. There would be no special treatment and physicians would have to uphold any terms imposed on in-network providers, including agreeing to reimbursement rates, quality standards, and other terms. If they agree, the patient’s visit would be treated like an in-network visit.
“We don’t see that such a change would negatively affect cost of health care,” Dr. Milroy said. “In fact, we think it would actually increase competition.”
If voters agree and vote positively on the initiative, it will have the force of law, according to Dr. Milroy.
Illinois voters will be asked to vote yes or no on whether any insurance plan in the state that offers prescription drug coverage “be required to include prescription birth control as part of that coverage.”
How that is to be implemented and what exactly would be covered as part of prescription birth control would be determined when the state legislature crafted a bill following voters’ approval of the question, which would leave the question of whether emergency contraception would be covered.
Dr. Maura P. Quinlan, chair of the Illinois Section of the American Congress of Obstetricians and Gynecologists, said in an interview that the ballot initiative is a way for voters to weigh in on the debate, noting cases like the recent Hobby Lobby Supreme Court decision had “no role for voters in Illinois to say how they feel about this.”
In general, the Illinois section supports the ballot initiative, commenting that while there might be costs associated with coverage, “it is so much cheaper to cover the cost to prevent an unplanned pregnancy than to pay for the pregnancy, the care of the child, etc. Always, preventive measures are much cheaper when insurance is trying to decide what they cover,” said Dr. Quinlan, who is in private practice in La Grange, Ill.
In Illinois, the ballot question does not have the force of law but would require the state legislature to enact a law to implement the initiative.
In another ballot initiative, Arizona voters will be asked to decide whether terminal patients in the state should have access to experimental drugs that have not yet received FDA approval.
According to the text of the “Terminal Patients’ Right to Try” act, an eligible patient must have a terminal illness as determined by the person’s physician, and the physician has determined there is “no comparable or satisfactory” FDA-approved treatment option “available to diagnose, monitor, or treat the disease or condition involved and that the probable risk to the person from the investigational drug, biological product, or device is not greater than the probable risk from the disease or condition.”
Products in question need to have successfully undergone phase I study and remain under clinical investigation. Manufacturers would not be required to provide access to the investigational drug, and it would be up to the company as to whether it collects compensation for the product or requires data collection on the drug’s effects as part of providing access to the product.
Similarly, insurance companies would not be required to cover access to the investigational product.
The measure also provides protections for the physician, stating that a state regulatory authority cannot take action against a physician’s license “based solely on a physician’s recommendation to an eligible patient regarding or prescribing for or treatment with an investigational drug, biological product, or device.”
The language of the ballot measure passed the state House on March 4 and state Senate on April 15.
South Dakota voters’ decision on an “any willing provider” ballot initiative is among a number of health care–related ballot initiatives that will be voted on in the upcoming midterm elections.
Others include a measure in Illinois that would require insurance providers that have prescription drug coverage to provide prescription contraceptives, and an Arizona ballot question regarding terminally ill patients’ access to experimental drugs.
If approved, South Dakota’s Initiative Measure 17 would allow providers who are willing to meet a health insurer’s coverage terms to provide health care services to insured patients without those patients incurring any out-of-network fees.
In recent years, the state has seen a significant increase in the number of closed and narrow provider networks, noted Dr. Mary J. Milroy, president of the South Dakota State Medical Association. That has disrupted the patient-physician relationship as patients find their long-time physicians are no longer in their health plan’s networks, said Dr. Milroy, a general surgeon from Yankton, S.D.
“Most patients don’t automatically choose their insurance company,” Dr. Milroy said in an interview. Employers can change employees’ insurance coverage, or coverage could shift with an employment change.
“If your personal physician, who maybe has been taking care of you for years, is not included in the panel for the new plan, then you have to switch or you have to incur out-of-pocket costs,” she explained. “We do not think that is good for continued and comprehensive medical care.”
Under the ballot question, physicians not in a patient’s insurance network but who want to continue a relationship with that patient would simply have to agree to the terms that the insurance provider has for physicians in its network. There would be no special treatment and physicians would have to uphold any terms imposed on in-network providers, including agreeing to reimbursement rates, quality standards, and other terms. If they agree, the patient’s visit would be treated like an in-network visit.
“We don’t see that such a change would negatively affect cost of health care,” Dr. Milroy said. “In fact, we think it would actually increase competition.”
If voters agree and vote positively on the initiative, it will have the force of law, according to Dr. Milroy.
Illinois voters will be asked to vote yes or no on whether any insurance plan in the state that offers prescription drug coverage “be required to include prescription birth control as part of that coverage.”
How that is to be implemented and what exactly would be covered as part of prescription birth control would be determined when the state legislature crafted a bill following voters’ approval of the question, which would leave the question of whether emergency contraception would be covered.
Dr. Maura P. Quinlan, chair of the Illinois Section of the American Congress of Obstetricians and Gynecologists, said in an interview that the ballot initiative is a way for voters to weigh in on the debate, noting cases like the recent Hobby Lobby Supreme Court decision had “no role for voters in Illinois to say how they feel about this.”
In general, the Illinois section supports the ballot initiative, commenting that while there might be costs associated with coverage, “it is so much cheaper to cover the cost to prevent an unplanned pregnancy than to pay for the pregnancy, the care of the child, etc. Always, preventive measures are much cheaper when insurance is trying to decide what they cover,” said Dr. Quinlan, who is in private practice in La Grange, Ill.
In Illinois, the ballot question does not have the force of law but would require the state legislature to enact a law to implement the initiative.
In another ballot initiative, Arizona voters will be asked to decide whether terminal patients in the state should have access to experimental drugs that have not yet received FDA approval.
According to the text of the “Terminal Patients’ Right to Try” act, an eligible patient must have a terminal illness as determined by the person’s physician, and the physician has determined there is “no comparable or satisfactory” FDA-approved treatment option “available to diagnose, monitor, or treat the disease or condition involved and that the probable risk to the person from the investigational drug, biological product, or device is not greater than the probable risk from the disease or condition.”
Products in question need to have successfully undergone phase I study and remain under clinical investigation. Manufacturers would not be required to provide access to the investigational drug, and it would be up to the company as to whether it collects compensation for the product or requires data collection on the drug’s effects as part of providing access to the product.
Similarly, insurance companies would not be required to cover access to the investigational product.
The measure also provides protections for the physician, stating that a state regulatory authority cannot take action against a physician’s license “based solely on a physician’s recommendation to an eligible patient regarding or prescribing for or treatment with an investigational drug, biological product, or device.”
The language of the ballot measure passed the state House on March 4 and state Senate on April 15.
More docs need to use available Rx-monitoring programs to help curb opioid abuse
WASHINGTON – The prescription drug–monitoring programs that exist in every state are not going to make a dent in opioid abuse unless physicians use them.
Because each state governs its own prescription drug–monitoring program (PDMP), the efficiency and effectiveness of each varies widely from the others. In the ideal, a PDMP collects information on which prescriptions are being filled by what patients as well as which physicians are prescribing the drugs. Information from the databases is used to help determine which patients might be doctor shopping for opioids as well as identify physicians who might be operating “pill mills” and contributing to the availability of narcotic pain medication that is used for other than clinical purposes.
Data from several studies have shown that in many instances, doctors do not realize the detail and usefulness of data from PDMPs, Allan Coukell, senior director for drugs and medical devices at Pew Charitable Trusts, Washington, said at a panel discussion on prescription drug abuse hosted by the Alliance for Health Reform and the Pharmaceutical Care Management Association, the industry lobby for pharmacy benefit managers.
When shown data on a specific patient, a physician was often “surprised to know how many other physicians that patient was seeing, and having that information changed their prescribing,” Mr. Coukell said, noting that in some cases, the information led to physicians refusing to prescribe pain medication and in others, it eased fears that a patient might be doctor shopping, giving the physician some peace of mind about writing a prescription for a narcotic.
Panelist Dr. Sarah Chouinard, medical director of Community Care of West Virginia, noted that physicians often are surprised when presented with data collected by PDMPs about their own individual prescribing habits.
“Eight out of 10 people were very surprised at the number of hydrocodone prescriptions they had written in the last 3 months,” Dr. Chouinard said.
In addition, the culture of administering pain medicine has gone through a shift in the last 10 years that is contributing to the problem of how many pills are available.
“About 10 years ago, there were doctors wandering around with buttons that said ‘No Pain’ with a red circle and a line through it because we were accused of under treating pain,” she observed. “Now, the pendulum has swung in the opposite direction. They used to say, ‘Hey, we’ll get sued if we don’t write pain medicine for these people,’ and now it’s, ‘Gosh, don’t write anything, or we will be a pill mill.’ I think the real answer is getting back to the middle and allowing the word to be out there that you don’t have to use a narcotic for every bump.”
To that end, Dr. Chouinard shared a solution her community organization has implemented. She said that “none of the [family physicians] are equipped, myself included, to treat chronic pain. Chronic pain is a specialty. ... It requires special training. The training that we as family doctors get now, after residency, is a mandatory 3 hours every 2 years.”
So Community Health of West Virgina hired an anesthetist who is not interested in family medicine but rather has a special interest in addictions medicine and outpatient pain medicine.
“Every one of our patients who has chronic pain [is sent] to this physician first,” Dr. Chouinard explained. “He does the work-up. He looks to see if the patients are amenable to any kind of alternatives and then sends those patients back to us as primary care doctors.”
After that, every patient gets a pain contract that essentially provides consent to have urine tested on a regular basis to track adherence, as well as provide pill counts and office visits as required by the doctors. The physicians also are required to regularly check the PDMP database.
Patients who need this kind of treatment do not complain that the requirements are burdensome, said Dr. Chouinard, who described the program as successful overall. She said 30% have stayed properly adherent to their prescription narcotics and are living within the agreements of their contracts, while another 20% were taken off their medication because they were able to be placed on alternate, nonopioid therapies. About 30% ended up recommended for or enrolled in an addiction program, while 20% failed to maintain their contracts, and thus were unable to get their prescriptions.
Dr. Chouinard said a program like this could easily be rolled out across the country to help address the opioid abuse problem, as well as help remove primary care doctors from the prescribing loop.
“None of these people went into medicine because they had an interest in treating chronic pain,” she said.
In keeping with the overall message of getting doctors to use PDMPs more, Mr. Coukell said that getting this information integrated into electronic health records is “the Holy Grail,” though he added that getting practice alerts are a good short-term fix. He also said that getting consistency of reporting practice uniform across states and getting more states to trade information also was key, as is getting rules in place to allow someone in the office other than the doctor to have access to the PDMP databases (which some states do allow).
Centers for Disease Control and Prevention Director of the Division of Unintentional Injury Prevention Grant Baldwin, Ph.D., concurred.
“Providers have a limited amount of time to see patients,” Dr. Baldwin said. “Integrating all of these fixes will not necessarily extend the amount of time, but it actually makes it easier for the health care team to do their job in an efficient manner in that same 10-15 minute time."
WASHINGTON – The prescription drug–monitoring programs that exist in every state are not going to make a dent in opioid abuse unless physicians use them.
Because each state governs its own prescription drug–monitoring program (PDMP), the efficiency and effectiveness of each varies widely from the others. In the ideal, a PDMP collects information on which prescriptions are being filled by what patients as well as which physicians are prescribing the drugs. Information from the databases is used to help determine which patients might be doctor shopping for opioids as well as identify physicians who might be operating “pill mills” and contributing to the availability of narcotic pain medication that is used for other than clinical purposes.
Data from several studies have shown that in many instances, doctors do not realize the detail and usefulness of data from PDMPs, Allan Coukell, senior director for drugs and medical devices at Pew Charitable Trusts, Washington, said at a panel discussion on prescription drug abuse hosted by the Alliance for Health Reform and the Pharmaceutical Care Management Association, the industry lobby for pharmacy benefit managers.
When shown data on a specific patient, a physician was often “surprised to know how many other physicians that patient was seeing, and having that information changed their prescribing,” Mr. Coukell said, noting that in some cases, the information led to physicians refusing to prescribe pain medication and in others, it eased fears that a patient might be doctor shopping, giving the physician some peace of mind about writing a prescription for a narcotic.
Panelist Dr. Sarah Chouinard, medical director of Community Care of West Virginia, noted that physicians often are surprised when presented with data collected by PDMPs about their own individual prescribing habits.
“Eight out of 10 people were very surprised at the number of hydrocodone prescriptions they had written in the last 3 months,” Dr. Chouinard said.
In addition, the culture of administering pain medicine has gone through a shift in the last 10 years that is contributing to the problem of how many pills are available.
“About 10 years ago, there were doctors wandering around with buttons that said ‘No Pain’ with a red circle and a line through it because we were accused of under treating pain,” she observed. “Now, the pendulum has swung in the opposite direction. They used to say, ‘Hey, we’ll get sued if we don’t write pain medicine for these people,’ and now it’s, ‘Gosh, don’t write anything, or we will be a pill mill.’ I think the real answer is getting back to the middle and allowing the word to be out there that you don’t have to use a narcotic for every bump.”
To that end, Dr. Chouinard shared a solution her community organization has implemented. She said that “none of the [family physicians] are equipped, myself included, to treat chronic pain. Chronic pain is a specialty. ... It requires special training. The training that we as family doctors get now, after residency, is a mandatory 3 hours every 2 years.”
So Community Health of West Virgina hired an anesthetist who is not interested in family medicine but rather has a special interest in addictions medicine and outpatient pain medicine.
“Every one of our patients who has chronic pain [is sent] to this physician first,” Dr. Chouinard explained. “He does the work-up. He looks to see if the patients are amenable to any kind of alternatives and then sends those patients back to us as primary care doctors.”
After that, every patient gets a pain contract that essentially provides consent to have urine tested on a regular basis to track adherence, as well as provide pill counts and office visits as required by the doctors. The physicians also are required to regularly check the PDMP database.
Patients who need this kind of treatment do not complain that the requirements are burdensome, said Dr. Chouinard, who described the program as successful overall. She said 30% have stayed properly adherent to their prescription narcotics and are living within the agreements of their contracts, while another 20% were taken off their medication because they were able to be placed on alternate, nonopioid therapies. About 30% ended up recommended for or enrolled in an addiction program, while 20% failed to maintain their contracts, and thus were unable to get their prescriptions.
Dr. Chouinard said a program like this could easily be rolled out across the country to help address the opioid abuse problem, as well as help remove primary care doctors from the prescribing loop.
“None of these people went into medicine because they had an interest in treating chronic pain,” she said.
In keeping with the overall message of getting doctors to use PDMPs more, Mr. Coukell said that getting this information integrated into electronic health records is “the Holy Grail,” though he added that getting practice alerts are a good short-term fix. He also said that getting consistency of reporting practice uniform across states and getting more states to trade information also was key, as is getting rules in place to allow someone in the office other than the doctor to have access to the PDMP databases (which some states do allow).
Centers for Disease Control and Prevention Director of the Division of Unintentional Injury Prevention Grant Baldwin, Ph.D., concurred.
“Providers have a limited amount of time to see patients,” Dr. Baldwin said. “Integrating all of these fixes will not necessarily extend the amount of time, but it actually makes it easier for the health care team to do their job in an efficient manner in that same 10-15 minute time."
WASHINGTON – The prescription drug–monitoring programs that exist in every state are not going to make a dent in opioid abuse unless physicians use them.
Because each state governs its own prescription drug–monitoring program (PDMP), the efficiency and effectiveness of each varies widely from the others. In the ideal, a PDMP collects information on which prescriptions are being filled by what patients as well as which physicians are prescribing the drugs. Information from the databases is used to help determine which patients might be doctor shopping for opioids as well as identify physicians who might be operating “pill mills” and contributing to the availability of narcotic pain medication that is used for other than clinical purposes.
Data from several studies have shown that in many instances, doctors do not realize the detail and usefulness of data from PDMPs, Allan Coukell, senior director for drugs and medical devices at Pew Charitable Trusts, Washington, said at a panel discussion on prescription drug abuse hosted by the Alliance for Health Reform and the Pharmaceutical Care Management Association, the industry lobby for pharmacy benefit managers.
When shown data on a specific patient, a physician was often “surprised to know how many other physicians that patient was seeing, and having that information changed their prescribing,” Mr. Coukell said, noting that in some cases, the information led to physicians refusing to prescribe pain medication and in others, it eased fears that a patient might be doctor shopping, giving the physician some peace of mind about writing a prescription for a narcotic.
Panelist Dr. Sarah Chouinard, medical director of Community Care of West Virginia, noted that physicians often are surprised when presented with data collected by PDMPs about their own individual prescribing habits.
“Eight out of 10 people were very surprised at the number of hydrocodone prescriptions they had written in the last 3 months,” Dr. Chouinard said.
In addition, the culture of administering pain medicine has gone through a shift in the last 10 years that is contributing to the problem of how many pills are available.
“About 10 years ago, there were doctors wandering around with buttons that said ‘No Pain’ with a red circle and a line through it because we were accused of under treating pain,” she observed. “Now, the pendulum has swung in the opposite direction. They used to say, ‘Hey, we’ll get sued if we don’t write pain medicine for these people,’ and now it’s, ‘Gosh, don’t write anything, or we will be a pill mill.’ I think the real answer is getting back to the middle and allowing the word to be out there that you don’t have to use a narcotic for every bump.”
To that end, Dr. Chouinard shared a solution her community organization has implemented. She said that “none of the [family physicians] are equipped, myself included, to treat chronic pain. Chronic pain is a specialty. ... It requires special training. The training that we as family doctors get now, after residency, is a mandatory 3 hours every 2 years.”
So Community Health of West Virgina hired an anesthetist who is not interested in family medicine but rather has a special interest in addictions medicine and outpatient pain medicine.
“Every one of our patients who has chronic pain [is sent] to this physician first,” Dr. Chouinard explained. “He does the work-up. He looks to see if the patients are amenable to any kind of alternatives and then sends those patients back to us as primary care doctors.”
After that, every patient gets a pain contract that essentially provides consent to have urine tested on a regular basis to track adherence, as well as provide pill counts and office visits as required by the doctors. The physicians also are required to regularly check the PDMP database.
Patients who need this kind of treatment do not complain that the requirements are burdensome, said Dr. Chouinard, who described the program as successful overall. She said 30% have stayed properly adherent to their prescription narcotics and are living within the agreements of their contracts, while another 20% were taken off their medication because they were able to be placed on alternate, nonopioid therapies. About 30% ended up recommended for or enrolled in an addiction program, while 20% failed to maintain their contracts, and thus were unable to get their prescriptions.
Dr. Chouinard said a program like this could easily be rolled out across the country to help address the opioid abuse problem, as well as help remove primary care doctors from the prescribing loop.
“None of these people went into medicine because they had an interest in treating chronic pain,” she said.
In keeping with the overall message of getting doctors to use PDMPs more, Mr. Coukell said that getting this information integrated into electronic health records is “the Holy Grail,” though he added that getting practice alerts are a good short-term fix. He also said that getting consistency of reporting practice uniform across states and getting more states to trade information also was key, as is getting rules in place to allow someone in the office other than the doctor to have access to the PDMP databases (which some states do allow).
Centers for Disease Control and Prevention Director of the Division of Unintentional Injury Prevention Grant Baldwin, Ph.D., concurred.
“Providers have a limited amount of time to see patients,” Dr. Baldwin said. “Integrating all of these fixes will not necessarily extend the amount of time, but it actually makes it easier for the health care team to do their job in an efficient manner in that same 10-15 minute time."
AT A PEW CHARITABLE TRUSTS–HOSTED PANEL
New modeling tool shows rapid, large-scale response can contain Ebola outbreak
A quick, large-scale response to an Ebola outbreak can contain it and actually bend the curve to limit new cases, according to a new modeling tool released by the Centers for Disease Control and Prevention.
Announced Sept. 23, the tool, EbolaResponse, allows for estimations of projected cases based on various response scenarios. Use of the tool can demonstrate how interventions can help slow and ultimately stop an Ebola epidemic.
“The EbolaResponse modeling tool is intended to help local governments and international responders generate short-term estimates of the Ebola situation in countries, districts, and villages,” the CDC said in a fact sheet on the new tool.
Speaking during a same-day press conference call, CDC Director Thomas R. Frieden said that the model shows something other models out there do not – that a surge in response “can break the back of the epidemic. … [I]f you get enough people effectively isolated, the epidemic can be stopped and, related to that, when you reach a high enough number [with isolation and treatment] … the number of cases plummets rapidly, almost as rapidly as the exponential rise we are seeing now.”
Dr. Frieden also noted the model’s cautionary tale: “For each month of delay, there is a big increase in the number of cases, and it gets much more difficult to control the epidemic.”
The CDC, in its latest Morbidity and Mortality Weekly Report, used the tool to estimate, based on various scenarios, the number of cases in Liberia and Sierra Leone, which offered a range of scenarios and put the number of cases at between 550,000 and 1.4 million by Jan. 20, 2015, but Dr. Frieden stressed that the number was generated a few weeks ago and is not based on the latest information that would bring those numbers down. The tool is available as a free download from the agency.
A quick, large-scale response to an Ebola outbreak can contain it and actually bend the curve to limit new cases, according to a new modeling tool released by the Centers for Disease Control and Prevention.
Announced Sept. 23, the tool, EbolaResponse, allows for estimations of projected cases based on various response scenarios. Use of the tool can demonstrate how interventions can help slow and ultimately stop an Ebola epidemic.
“The EbolaResponse modeling tool is intended to help local governments and international responders generate short-term estimates of the Ebola situation in countries, districts, and villages,” the CDC said in a fact sheet on the new tool.
Speaking during a same-day press conference call, CDC Director Thomas R. Frieden said that the model shows something other models out there do not – that a surge in response “can break the back of the epidemic. … [I]f you get enough people effectively isolated, the epidemic can be stopped and, related to that, when you reach a high enough number [with isolation and treatment] … the number of cases plummets rapidly, almost as rapidly as the exponential rise we are seeing now.”
Dr. Frieden also noted the model’s cautionary tale: “For each month of delay, there is a big increase in the number of cases, and it gets much more difficult to control the epidemic.”
The CDC, in its latest Morbidity and Mortality Weekly Report, used the tool to estimate, based on various scenarios, the number of cases in Liberia and Sierra Leone, which offered a range of scenarios and put the number of cases at between 550,000 and 1.4 million by Jan. 20, 2015, but Dr. Frieden stressed that the number was generated a few weeks ago and is not based on the latest information that would bring those numbers down. The tool is available as a free download from the agency.
A quick, large-scale response to an Ebola outbreak can contain it and actually bend the curve to limit new cases, according to a new modeling tool released by the Centers for Disease Control and Prevention.
Announced Sept. 23, the tool, EbolaResponse, allows for estimations of projected cases based on various response scenarios. Use of the tool can demonstrate how interventions can help slow and ultimately stop an Ebola epidemic.
“The EbolaResponse modeling tool is intended to help local governments and international responders generate short-term estimates of the Ebola situation in countries, districts, and villages,” the CDC said in a fact sheet on the new tool.
Speaking during a same-day press conference call, CDC Director Thomas R. Frieden said that the model shows something other models out there do not – that a surge in response “can break the back of the epidemic. … [I]f you get enough people effectively isolated, the epidemic can be stopped and, related to that, when you reach a high enough number [with isolation and treatment] … the number of cases plummets rapidly, almost as rapidly as the exponential rise we are seeing now.”
Dr. Frieden also noted the model’s cautionary tale: “For each month of delay, there is a big increase in the number of cases, and it gets much more difficult to control the epidemic.”
The CDC, in its latest Morbidity and Mortality Weekly Report, used the tool to estimate, based on various scenarios, the number of cases in Liberia and Sierra Leone, which offered a range of scenarios and put the number of cases at between 550,000 and 1.4 million by Jan. 20, 2015, but Dr. Frieden stressed that the number was generated a few weeks ago and is not based on the latest information that would bring those numbers down. The tool is available as a free download from the agency.
Telemetry guidelines built into order system saved $4.8 million annually
Embedding the American Heart Association’s recommendations for addressing the use of nonintensive care unit cardiac telemetry in an electronic ordering system reduced telemetry use without affecting patient safety.
The hardwiring into the electronic ordering system of AHA’s guidelines were implemented in Christiana Healthcare System of Newark, Del., on March 18, 2013. An examination of cardiac telemetry orders and associated costs from Dec. 31, 2012, to Aug, 12, 2013, found a reduction in telemetry orders.
Following the implementation, there was an “immediate and sustained reduction in the mean weekly number of telemetry orders from 1,032.3 to 593.2 and the mean duration of telemetry fell from 57.8 to 30.9 hours (reductions of 43% and 47%, respectively).”
Reducing non-ICU telemetry use was a part of the March 2013 list of the Society of Hospital Medicine in the Choosing Wisely campaign.
Research results were published online Sept. 22 in JAMA Internal Medicine.
The estimated total daily cost to deliver telemetry was $53.44 per telemetry patient, the authors wrote. The mean daily cost for non-ICU cardiac telemetry decreased from $18,971 to $5,772. Hardwiring the guidelines into the electronic ordering system is estimated to save Christiana Healthcare System $4.8 million annually.
“Although overuse of cardiac telemetry in non-ICU settings is widely recognized, there is a paucity of literature outlining successful and safe strategies addressing this concern,” Dr. Robert Dressler of Christiana Healthcare and his colleagues wrote in JAMA Internal Medicine. “Our project led to a sustained 70% reduction in telemetry use without adversely affecting patient safety. In fact, patient safety may be enhanced by reducing the potential for alarm fatigue and provider workflow interruption.”
Researchers reported no conflicts of interest.
While results of the hardwiring of the American Heart Association’s guidelines on telemetry into an electronic ordering system to help reduce use in the nonintensive care setting shows promise, there needs to be a randomized trial gather the evidence needed to get this into general practice, according to Dr. Nadar Najafi.
The substantial reduction at Christiana Healthcare System suggests that telemetry is overused and the AHA guidelines can safely reduce unnecessary monitoring. Since the guidelines exclude patients who do not have a primary cardiac condition, the intervention safely reduced or eliminated monitoring these patients. “It is a reminder of the absence of known clinical benefit of using telemetry on medical and surgical services,” Dr. Najafi wrote in commentary published online Sept. 22 in JAMA Internal Medicine.
“We are entering an era of unprecedented technological advancement in medicine,” he continues. “Unfortunately, technology often overtakes scientific evidence in the race to the bedside. We must remain vigilant against this outcome in the name of patient safety and cost.”
Dr. Najafi works in the division of hospital medicine at the University of California, San Francisco.
While results of the hardwiring of the American Heart Association’s guidelines on telemetry into an electronic ordering system to help reduce use in the nonintensive care setting shows promise, there needs to be a randomized trial gather the evidence needed to get this into general practice, according to Dr. Nadar Najafi.
The substantial reduction at Christiana Healthcare System suggests that telemetry is overused and the AHA guidelines can safely reduce unnecessary monitoring. Since the guidelines exclude patients who do not have a primary cardiac condition, the intervention safely reduced or eliminated monitoring these patients. “It is a reminder of the absence of known clinical benefit of using telemetry on medical and surgical services,” Dr. Najafi wrote in commentary published online Sept. 22 in JAMA Internal Medicine.
“We are entering an era of unprecedented technological advancement in medicine,” he continues. “Unfortunately, technology often overtakes scientific evidence in the race to the bedside. We must remain vigilant against this outcome in the name of patient safety and cost.”
Dr. Najafi works in the division of hospital medicine at the University of California, San Francisco.
While results of the hardwiring of the American Heart Association’s guidelines on telemetry into an electronic ordering system to help reduce use in the nonintensive care setting shows promise, there needs to be a randomized trial gather the evidence needed to get this into general practice, according to Dr. Nadar Najafi.
The substantial reduction at Christiana Healthcare System suggests that telemetry is overused and the AHA guidelines can safely reduce unnecessary monitoring. Since the guidelines exclude patients who do not have a primary cardiac condition, the intervention safely reduced or eliminated monitoring these patients. “It is a reminder of the absence of known clinical benefit of using telemetry on medical and surgical services,” Dr. Najafi wrote in commentary published online Sept. 22 in JAMA Internal Medicine.
“We are entering an era of unprecedented technological advancement in medicine,” he continues. “Unfortunately, technology often overtakes scientific evidence in the race to the bedside. We must remain vigilant against this outcome in the name of patient safety and cost.”
Dr. Najafi works in the division of hospital medicine at the University of California, San Francisco.
Embedding the American Heart Association’s recommendations for addressing the use of nonintensive care unit cardiac telemetry in an electronic ordering system reduced telemetry use without affecting patient safety.
The hardwiring into the electronic ordering system of AHA’s guidelines were implemented in Christiana Healthcare System of Newark, Del., on March 18, 2013. An examination of cardiac telemetry orders and associated costs from Dec. 31, 2012, to Aug, 12, 2013, found a reduction in telemetry orders.
Following the implementation, there was an “immediate and sustained reduction in the mean weekly number of telemetry orders from 1,032.3 to 593.2 and the mean duration of telemetry fell from 57.8 to 30.9 hours (reductions of 43% and 47%, respectively).”
Reducing non-ICU telemetry use was a part of the March 2013 list of the Society of Hospital Medicine in the Choosing Wisely campaign.
Research results were published online Sept. 22 in JAMA Internal Medicine.
The estimated total daily cost to deliver telemetry was $53.44 per telemetry patient, the authors wrote. The mean daily cost for non-ICU cardiac telemetry decreased from $18,971 to $5,772. Hardwiring the guidelines into the electronic ordering system is estimated to save Christiana Healthcare System $4.8 million annually.
“Although overuse of cardiac telemetry in non-ICU settings is widely recognized, there is a paucity of literature outlining successful and safe strategies addressing this concern,” Dr. Robert Dressler of Christiana Healthcare and his colleagues wrote in JAMA Internal Medicine. “Our project led to a sustained 70% reduction in telemetry use without adversely affecting patient safety. In fact, patient safety may be enhanced by reducing the potential for alarm fatigue and provider workflow interruption.”
Researchers reported no conflicts of interest.
Embedding the American Heart Association’s recommendations for addressing the use of nonintensive care unit cardiac telemetry in an electronic ordering system reduced telemetry use without affecting patient safety.
The hardwiring into the electronic ordering system of AHA’s guidelines were implemented in Christiana Healthcare System of Newark, Del., on March 18, 2013. An examination of cardiac telemetry orders and associated costs from Dec. 31, 2012, to Aug, 12, 2013, found a reduction in telemetry orders.
Following the implementation, there was an “immediate and sustained reduction in the mean weekly number of telemetry orders from 1,032.3 to 593.2 and the mean duration of telemetry fell from 57.8 to 30.9 hours (reductions of 43% and 47%, respectively).”
Reducing non-ICU telemetry use was a part of the March 2013 list of the Society of Hospital Medicine in the Choosing Wisely campaign.
Research results were published online Sept. 22 in JAMA Internal Medicine.
The estimated total daily cost to deliver telemetry was $53.44 per telemetry patient, the authors wrote. The mean daily cost for non-ICU cardiac telemetry decreased from $18,971 to $5,772. Hardwiring the guidelines into the electronic ordering system is estimated to save Christiana Healthcare System $4.8 million annually.
“Although overuse of cardiac telemetry in non-ICU settings is widely recognized, there is a paucity of literature outlining successful and safe strategies addressing this concern,” Dr. Robert Dressler of Christiana Healthcare and his colleagues wrote in JAMA Internal Medicine. “Our project led to a sustained 70% reduction in telemetry use without adversely affecting patient safety. In fact, patient safety may be enhanced by reducing the potential for alarm fatigue and provider workflow interruption.”
Researchers reported no conflicts of interest.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Following AHA guidelines on non-ICU telemetry use reduced usage without adverse patient outcomes.
Major finding: Use of guidelines reduced mean weekly telemetry orders from 1,032.3 to 593.2 and mean duration fell from 57.8 hours to 30.9 hours.
Data source: A review of non-ICU telemetry orders in the Christiana Healthcare System from 2013.
Disclosures: Research was supported by the Delaware IDeA Networks of Biomedical Research Excellence, with grants from the National Institute of General Medical Sciences. No conflicts of interest were reported.
Congress poised to act on 2015 meaningful use full year reporting requirement
WASHINGTON – Members of Congress are moving to push legislation through that would shorten the reporting period for stage 2 meaningful use in 2015 if the Centers for Medicare & Medicaid Services does not act.
At issue is the requirement that eligible physicians, hospitals, and other providers must attest that they meet stage 2 requirements for the full 365-day period in 2015 (beginning Oct. 1, 2014, for hospitals and Jan 1, 2015, for physicians) or face a 1% reduction in Medicare payments as a penalty for not adopting the stage 2 requirements.
“Only 9% of hospitals in this country right now are up to the [stage 2] mandate on meaningful use,” Rep. Renee Ellmers (R-N.C.) said Sept. 18 at the HIMSS Policy Summit. “There’s only 1% of physician offices in this country that are up to the meaningful use mandate.”
Rep. Ellmers and Rep. Jim Matheson (D-Utah), have introduced the Flexibility in Health IT Reporting Act (H.R. 5481), which would alter those reporting requirements so eligible providers and hospitals would have to attest that they met stage 2 requirements for a 3-month period for 2015 rather than meeting the current regulations, which call for a full year. This would give doctors and hospitals extra time to ensure electronic health record systems are properly upgraded for the next level of requirements.
“My hope is that CMS is going to hear from so many of you, so many from industry that they will actually end up making the change on their own without us actually having to vote on it,” Rep. Ellmers said. “If we do have to vote on it, it will be when we come back in the lame-duck session. I don’t want to have to wait that long.”
She suggested that hospitals could question whether it is worth it to press for stage 2 attestation or just take the 1% penalty.
“There will already have been $24 billion of hard-earned taxpayer dollars that have been invested in this,” she said. “That is going by the wayside if hospitals are not participating in meaningful use,”
Robert Tennant, senior policy adviser at the Medical Group Management Association, made a similar observation about the physician community. He noted that physicians who are eligible to receive incentive bonuses under the meaningful use program and have been participating since the program began in 2011 have already received $38,000 of the $44,000 maximum bonus.
“To move to stage 2 will only allow you to receive a maximum of $6,000, so the money is somewhat less now and so what we don’t want to do is add further discouragement for [eligible providers] to move to stage 2 of the program,” Mr. Tennant said in an interview.
The American Medical Association voiced its support for the bill in a letter to Rep. Ellmers.
At a separate press conference Sept. 18 as part of National Health IT Week, Rep. Phil Gingrey (R-Ga.), also voiced his support for the bill.
WASHINGTON – Members of Congress are moving to push legislation through that would shorten the reporting period for stage 2 meaningful use in 2015 if the Centers for Medicare & Medicaid Services does not act.
At issue is the requirement that eligible physicians, hospitals, and other providers must attest that they meet stage 2 requirements for the full 365-day period in 2015 (beginning Oct. 1, 2014, for hospitals and Jan 1, 2015, for physicians) or face a 1% reduction in Medicare payments as a penalty for not adopting the stage 2 requirements.
“Only 9% of hospitals in this country right now are up to the [stage 2] mandate on meaningful use,” Rep. Renee Ellmers (R-N.C.) said Sept. 18 at the HIMSS Policy Summit. “There’s only 1% of physician offices in this country that are up to the meaningful use mandate.”
Rep. Ellmers and Rep. Jim Matheson (D-Utah), have introduced the Flexibility in Health IT Reporting Act (H.R. 5481), which would alter those reporting requirements so eligible providers and hospitals would have to attest that they met stage 2 requirements for a 3-month period for 2015 rather than meeting the current regulations, which call for a full year. This would give doctors and hospitals extra time to ensure electronic health record systems are properly upgraded for the next level of requirements.
“My hope is that CMS is going to hear from so many of you, so many from industry that they will actually end up making the change on their own without us actually having to vote on it,” Rep. Ellmers said. “If we do have to vote on it, it will be when we come back in the lame-duck session. I don’t want to have to wait that long.”
She suggested that hospitals could question whether it is worth it to press for stage 2 attestation or just take the 1% penalty.
“There will already have been $24 billion of hard-earned taxpayer dollars that have been invested in this,” she said. “That is going by the wayside if hospitals are not participating in meaningful use,”
Robert Tennant, senior policy adviser at the Medical Group Management Association, made a similar observation about the physician community. He noted that physicians who are eligible to receive incentive bonuses under the meaningful use program and have been participating since the program began in 2011 have already received $38,000 of the $44,000 maximum bonus.
“To move to stage 2 will only allow you to receive a maximum of $6,000, so the money is somewhat less now and so what we don’t want to do is add further discouragement for [eligible providers] to move to stage 2 of the program,” Mr. Tennant said in an interview.
The American Medical Association voiced its support for the bill in a letter to Rep. Ellmers.
At a separate press conference Sept. 18 as part of National Health IT Week, Rep. Phil Gingrey (R-Ga.), also voiced his support for the bill.
WASHINGTON – Members of Congress are moving to push legislation through that would shorten the reporting period for stage 2 meaningful use in 2015 if the Centers for Medicare & Medicaid Services does not act.
At issue is the requirement that eligible physicians, hospitals, and other providers must attest that they meet stage 2 requirements for the full 365-day period in 2015 (beginning Oct. 1, 2014, for hospitals and Jan 1, 2015, for physicians) or face a 1% reduction in Medicare payments as a penalty for not adopting the stage 2 requirements.
“Only 9% of hospitals in this country right now are up to the [stage 2] mandate on meaningful use,” Rep. Renee Ellmers (R-N.C.) said Sept. 18 at the HIMSS Policy Summit. “There’s only 1% of physician offices in this country that are up to the meaningful use mandate.”
Rep. Ellmers and Rep. Jim Matheson (D-Utah), have introduced the Flexibility in Health IT Reporting Act (H.R. 5481), which would alter those reporting requirements so eligible providers and hospitals would have to attest that they met stage 2 requirements for a 3-month period for 2015 rather than meeting the current regulations, which call for a full year. This would give doctors and hospitals extra time to ensure electronic health record systems are properly upgraded for the next level of requirements.
“My hope is that CMS is going to hear from so many of you, so many from industry that they will actually end up making the change on their own without us actually having to vote on it,” Rep. Ellmers said. “If we do have to vote on it, it will be when we come back in the lame-duck session. I don’t want to have to wait that long.”
She suggested that hospitals could question whether it is worth it to press for stage 2 attestation or just take the 1% penalty.
“There will already have been $24 billion of hard-earned taxpayer dollars that have been invested in this,” she said. “That is going by the wayside if hospitals are not participating in meaningful use,”
Robert Tennant, senior policy adviser at the Medical Group Management Association, made a similar observation about the physician community. He noted that physicians who are eligible to receive incentive bonuses under the meaningful use program and have been participating since the program began in 2011 have already received $38,000 of the $44,000 maximum bonus.
“To move to stage 2 will only allow you to receive a maximum of $6,000, so the money is somewhat less now and so what we don’t want to do is add further discouragement for [eligible providers] to move to stage 2 of the program,” Mr. Tennant said in an interview.
The American Medical Association voiced its support for the bill in a letter to Rep. Ellmers.
At a separate press conference Sept. 18 as part of National Health IT Week, Rep. Phil Gingrey (R-Ga.), also voiced his support for the bill.
Bill requiring childproofing of e-cig refills advances
A bill that would require liquid nicotine vials, such as those used to refill electronic cigarettes, to have childproof caps is poised for full Senate consideration.
The Senate Commerce, Science, and Transportation Committee by a unanimous voice vote Sept, 17, approved the Child Nicotine Poisoning Prevention Act of 2014 (S. 2581). The bill is supported by organizations including the American Academy of Pediatricians, American College of Physicians, American College of Cardiology and American Academy of Otolaryngology-Head and Neck Surgery.
If enacted, the legislation would direct the Consumer Product Safety Commission to develop rules requiring childproof containers for liquid nicotine preparations.
“Our first priority is to make sure this stuff isn’t hurting our kids,” Sen. Bill Nelson (D-Fla.), the bill’s sponsor, said in a statement. “Then we can continue to look at whether or not additional steps need to be taken to protect the general public.”
Courtesy of Sen. Bill Nelson
A bill that would require liquid nicotine vials, such as those used to refill electronic cigarettes, to have childproof caps is poised for full Senate consideration.
The Senate Commerce, Science, and Transportation Committee by a unanimous voice vote Sept, 17, approved the Child Nicotine Poisoning Prevention Act of 2014 (S. 2581). The bill is supported by organizations including the American Academy of Pediatricians, American College of Physicians, American College of Cardiology and American Academy of Otolaryngology-Head and Neck Surgery.
If enacted, the legislation would direct the Consumer Product Safety Commission to develop rules requiring childproof containers for liquid nicotine preparations.
“Our first priority is to make sure this stuff isn’t hurting our kids,” Sen. Bill Nelson (D-Fla.), the bill’s sponsor, said in a statement. “Then we can continue to look at whether or not additional steps need to be taken to protect the general public.”
Courtesy of Sen. Bill Nelson
A bill that would require liquid nicotine vials, such as those used to refill electronic cigarettes, to have childproof caps is poised for full Senate consideration.
The Senate Commerce, Science, and Transportation Committee by a unanimous voice vote Sept, 17, approved the Child Nicotine Poisoning Prevention Act of 2014 (S. 2581). The bill is supported by organizations including the American Academy of Pediatricians, American College of Physicians, American College of Cardiology and American Academy of Otolaryngology-Head and Neck Surgery.
If enacted, the legislation would direct the Consumer Product Safety Commission to develop rules requiring childproof containers for liquid nicotine preparations.
“Our first priority is to make sure this stuff isn’t hurting our kids,” Sen. Bill Nelson (D-Fla.), the bill’s sponsor, said in a statement. “Then we can continue to look at whether or not additional steps need to be taken to protect the general public.”
Courtesy of Sen. Bill Nelson
FDA Weighs Its Oversight Role for Clinical Decision Support Tools
GAITHERSBURG, MD. – Testing to ensure the reliability of information from clinical decision support tools might become part of the health information technology oversight provided by the Food and Drug Administration, based on discussions at an FDA workshop.
"We will have to have some sort of follow-up system in place to make sure that systems do what they say they are going to do," American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld said during the workshop, which was held to solicit commentary on the recent FDASIA (Safety and Innovation Act) Health IT Report, a proposed framework for the regulation of health information technology.
In April, a report was issued by the FDA, the U.S. Department of Health & Human Services Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission.
The report defines clinical decision support tools as providing "knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health care." Examples of such tools include "computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant information."
The report adds that the "FDA does not intend to focus its regulatory oversight on these products/functionalities, even if they meet the statutory definition of a medical device," citing examples of drug-drug interaction alerts and drug allergy contradiction alerts; drug dosing calculators; reminders for preventive care; and suggestions for diagnosis based on patient-specific information in EHRs.
To ensure the reliability of these tools, however, some oversight of the algorithms used to generate that information will be needed.
Using oncology as an example, Dr. Lichtenfeld observed that certain tests important to cancer care can be inaccurate and that not everyone follows the same protocols when administering tests. "We’re going to have to have – and I say this with trepidation – an oversight to make sure the systems do what they say [they are going to do]." That way, there is an assurance that "when we do press the button, something really does work the way it’s supposed to work."
Dr. David S. Hirschorn, director of radiology informatics at Staten Island (N.Y.)University Hospital, noted that there needs to be a distinction between information coming from "a vendor that might have other interests" and information from best medical evidence.
The best clinical decision support tools will need to allow protocols to be updated to reflect the most up-to-date information. Examples include a feedback mechanism that allows doctors to correct mistakes in the protocol used to write the code and make changes based on advances in the knowledge and delivery of health care, he said.
Panelists also noted that any potential oversight needs to be balanced with the ability to innovate and that strict reliance on guidelines could keep physicians from using clinical decision support tools to their fullest capabilities.
GAITHERSBURG, MD. – Testing to ensure the reliability of information from clinical decision support tools might become part of the health information technology oversight provided by the Food and Drug Administration, based on discussions at an FDA workshop.
"We will have to have some sort of follow-up system in place to make sure that systems do what they say they are going to do," American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld said during the workshop, which was held to solicit commentary on the recent FDASIA (Safety and Innovation Act) Health IT Report, a proposed framework for the regulation of health information technology.
In April, a report was issued by the FDA, the U.S. Department of Health & Human Services Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission.
The report defines clinical decision support tools as providing "knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health care." Examples of such tools include "computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant information."
The report adds that the "FDA does not intend to focus its regulatory oversight on these products/functionalities, even if they meet the statutory definition of a medical device," citing examples of drug-drug interaction alerts and drug allergy contradiction alerts; drug dosing calculators; reminders for preventive care; and suggestions for diagnosis based on patient-specific information in EHRs.
To ensure the reliability of these tools, however, some oversight of the algorithms used to generate that information will be needed.
Using oncology as an example, Dr. Lichtenfeld observed that certain tests important to cancer care can be inaccurate and that not everyone follows the same protocols when administering tests. "We’re going to have to have – and I say this with trepidation – an oversight to make sure the systems do what they say [they are going to do]." That way, there is an assurance that "when we do press the button, something really does work the way it’s supposed to work."
Dr. David S. Hirschorn, director of radiology informatics at Staten Island (N.Y.)University Hospital, noted that there needs to be a distinction between information coming from "a vendor that might have other interests" and information from best medical evidence.
The best clinical decision support tools will need to allow protocols to be updated to reflect the most up-to-date information. Examples include a feedback mechanism that allows doctors to correct mistakes in the protocol used to write the code and make changes based on advances in the knowledge and delivery of health care, he said.
Panelists also noted that any potential oversight needs to be balanced with the ability to innovate and that strict reliance on guidelines could keep physicians from using clinical decision support tools to their fullest capabilities.
GAITHERSBURG, MD. – Testing to ensure the reliability of information from clinical decision support tools might become part of the health information technology oversight provided by the Food and Drug Administration, based on discussions at an FDA workshop.
"We will have to have some sort of follow-up system in place to make sure that systems do what they say they are going to do," American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld said during the workshop, which was held to solicit commentary on the recent FDASIA (Safety and Innovation Act) Health IT Report, a proposed framework for the regulation of health information technology.
In April, a report was issued by the FDA, the U.S. Department of Health & Human Services Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission.
The report defines clinical decision support tools as providing "knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health care." Examples of such tools include "computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant information."
The report adds that the "FDA does not intend to focus its regulatory oversight on these products/functionalities, even if they meet the statutory definition of a medical device," citing examples of drug-drug interaction alerts and drug allergy contradiction alerts; drug dosing calculators; reminders for preventive care; and suggestions for diagnosis based on patient-specific information in EHRs.
To ensure the reliability of these tools, however, some oversight of the algorithms used to generate that information will be needed.
Using oncology as an example, Dr. Lichtenfeld observed that certain tests important to cancer care can be inaccurate and that not everyone follows the same protocols when administering tests. "We’re going to have to have – and I say this with trepidation – an oversight to make sure the systems do what they say [they are going to do]." That way, there is an assurance that "when we do press the button, something really does work the way it’s supposed to work."
Dr. David S. Hirschorn, director of radiology informatics at Staten Island (N.Y.)University Hospital, noted that there needs to be a distinction between information coming from "a vendor that might have other interests" and information from best medical evidence.
The best clinical decision support tools will need to allow protocols to be updated to reflect the most up-to-date information. Examples include a feedback mechanism that allows doctors to correct mistakes in the protocol used to write the code and make changes based on advances in the knowledge and delivery of health care, he said.
Panelists also noted that any potential oversight needs to be balanced with the ability to innovate and that strict reliance on guidelines could keep physicians from using clinical decision support tools to their fullest capabilities.
FDA approves enzalutamide for chemo-naive metastatic prostate cancer
Enzalutamide, an androgen receptor blocker, has been approved by the Food and Drug Administration to treat men with metastatic castration-resistant prostate cancer who have not received chemotherapy, manufacturer Medivation announced Sept. 10.
The drug, which is marketed under the brand name Xtandi, received FDA approval in August 2012 as a second-line treatment for metastatic castration-resistant prostate cancer (MCRPC) in men previously receiving docetaxel.
Approval was based on the results of the PREVAIL phase III trial. Interim results of the trial were presented earlier this year at the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).
A same-day announcement by ASCO noted that the "pre-specified interim analysis for OS [overall survival] demonstrated a statistically significant improvement in patients who received enzalutamide," with a median overall survival of 32.4 months vs. 30.2 months in the placebo arm. "The OS improvement was supported by a statistically significant prolongation of [radiographic progression-free survival] in patients who received" the once-daily dose of 160 mg of enzalutamide, compared with placebo.
Additionally, the median time to initiation of cytotoxic chemotherapy was 28 months in the enzalutamide arm, compared with 10.8 months in the placebo arm.
The most common side effects in 10% or more of patients receiving enzalutamide from this trial and the randomized trial used for its initial approval were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight loss, headache, hypertension, and dizziness/vertigo.
According to its prescribing information, enzalutamide is being recommended at the 160-mg dose, taken orally with or without food.
Enzalutamide, an androgen receptor blocker, has been approved by the Food and Drug Administration to treat men with metastatic castration-resistant prostate cancer who have not received chemotherapy, manufacturer Medivation announced Sept. 10.
The drug, which is marketed under the brand name Xtandi, received FDA approval in August 2012 as a second-line treatment for metastatic castration-resistant prostate cancer (MCRPC) in men previously receiving docetaxel.
Approval was based on the results of the PREVAIL phase III trial. Interim results of the trial were presented earlier this year at the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).
A same-day announcement by ASCO noted that the "pre-specified interim analysis for OS [overall survival] demonstrated a statistically significant improvement in patients who received enzalutamide," with a median overall survival of 32.4 months vs. 30.2 months in the placebo arm. "The OS improvement was supported by a statistically significant prolongation of [radiographic progression-free survival] in patients who received" the once-daily dose of 160 mg of enzalutamide, compared with placebo.
Additionally, the median time to initiation of cytotoxic chemotherapy was 28 months in the enzalutamide arm, compared with 10.8 months in the placebo arm.
The most common side effects in 10% or more of patients receiving enzalutamide from this trial and the randomized trial used for its initial approval were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight loss, headache, hypertension, and dizziness/vertigo.
According to its prescribing information, enzalutamide is being recommended at the 160-mg dose, taken orally with or without food.
Enzalutamide, an androgen receptor blocker, has been approved by the Food and Drug Administration to treat men with metastatic castration-resistant prostate cancer who have not received chemotherapy, manufacturer Medivation announced Sept. 10.
The drug, which is marketed under the brand name Xtandi, received FDA approval in August 2012 as a second-line treatment for metastatic castration-resistant prostate cancer (MCRPC) in men previously receiving docetaxel.
Approval was based on the results of the PREVAIL phase III trial. Interim results of the trial were presented earlier this year at the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).
A same-day announcement by ASCO noted that the "pre-specified interim analysis for OS [overall survival] demonstrated a statistically significant improvement in patients who received enzalutamide," with a median overall survival of 32.4 months vs. 30.2 months in the placebo arm. "The OS improvement was supported by a statistically significant prolongation of [radiographic progression-free survival] in patients who received" the once-daily dose of 160 mg of enzalutamide, compared with placebo.
Additionally, the median time to initiation of cytotoxic chemotherapy was 28 months in the enzalutamide arm, compared with 10.8 months in the placebo arm.
The most common side effects in 10% or more of patients receiving enzalutamide from this trial and the randomized trial used for its initial approval were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight loss, headache, hypertension, and dizziness/vertigo.
According to its prescribing information, enzalutamide is being recommended at the 160-mg dose, taken orally with or without food.
EHRs rob physicians of 4 hours of free time per week
Using an electronic health records eats 48 minutes of doctors’ free time daily – or 4 hours per week – according to a survey of family physicians.
At least one data management function took more time when using an EHR than when using a paper-based system, according to 411 family physicians who responded to a survey conducted by the National Library of Medicine (NLM) and the American College of Physicians. The results were published Sept. 8 in JAMA Internal Medicine (2014 Sept. 8 [doi:10.1001/jamainternmed.2014.4506]).
Functions that took longer with an EHR included returning telephone calls; managing messages, refill requests, or new test results; writing visit notes; ordering and scheduling tests; finding and reviewing medical records; writing prescriptions; and reading colleagues; clinical notes.
Nearly 64% of respondents, all of whom were experienced EHR users, reported that "note writing took longer," according to Dr. Clement McDonald of NLM and his associates. "Surprisingly, a third (34%) reported that it took longer to find and review medical record data with the [EHR] than without, and a similar proportion, 32%, [reported] that it was slower to read other clinicians’ notes."
Respondents reported using a wide variety of systems, with 61 distinct EHR systems being identified. However, nine systems were used by 20 or more respondents and accounted for 79% (324) of all users responding to the survey. Of these nine, the Veterans Affairs’ Computer Patient Record System was associated with lowest amount of free time loss at less than 20 minutes per day.
"The loss of free time that our respondents reported was large and pervasive and could decrease access or increase the cost of care" Dr. McDonald wrote. "Policy makers should consider these time costs in future [EHR] mandates."
The authors reported no conflicts of interest.
The study was funded by the National Library of Medicine and the American College of Physicians. The authors reported no conflicts of interest.
Using an electronic health records eats 48 minutes of doctors’ free time daily – or 4 hours per week – according to a survey of family physicians.
At least one data management function took more time when using an EHR than when using a paper-based system, according to 411 family physicians who responded to a survey conducted by the National Library of Medicine (NLM) and the American College of Physicians. The results were published Sept. 8 in JAMA Internal Medicine (2014 Sept. 8 [doi:10.1001/jamainternmed.2014.4506]).
Functions that took longer with an EHR included returning telephone calls; managing messages, refill requests, or new test results; writing visit notes; ordering and scheduling tests; finding and reviewing medical records; writing prescriptions; and reading colleagues; clinical notes.
Nearly 64% of respondents, all of whom were experienced EHR users, reported that "note writing took longer," according to Dr. Clement McDonald of NLM and his associates. "Surprisingly, a third (34%) reported that it took longer to find and review medical record data with the [EHR] than without, and a similar proportion, 32%, [reported] that it was slower to read other clinicians’ notes."
Respondents reported using a wide variety of systems, with 61 distinct EHR systems being identified. However, nine systems were used by 20 or more respondents and accounted for 79% (324) of all users responding to the survey. Of these nine, the Veterans Affairs’ Computer Patient Record System was associated with lowest amount of free time loss at less than 20 minutes per day.
"The loss of free time that our respondents reported was large and pervasive and could decrease access or increase the cost of care" Dr. McDonald wrote. "Policy makers should consider these time costs in future [EHR] mandates."
The authors reported no conflicts of interest.
The study was funded by the National Library of Medicine and the American College of Physicians. The authors reported no conflicts of interest.
Using an electronic health records eats 48 minutes of doctors’ free time daily – or 4 hours per week – according to a survey of family physicians.
At least one data management function took more time when using an EHR than when using a paper-based system, according to 411 family physicians who responded to a survey conducted by the National Library of Medicine (NLM) and the American College of Physicians. The results were published Sept. 8 in JAMA Internal Medicine (2014 Sept. 8 [doi:10.1001/jamainternmed.2014.4506]).
Functions that took longer with an EHR included returning telephone calls; managing messages, refill requests, or new test results; writing visit notes; ordering and scheduling tests; finding and reviewing medical records; writing prescriptions; and reading colleagues; clinical notes.
Nearly 64% of respondents, all of whom were experienced EHR users, reported that "note writing took longer," according to Dr. Clement McDonald of NLM and his associates. "Surprisingly, a third (34%) reported that it took longer to find and review medical record data with the [EHR] than without, and a similar proportion, 32%, [reported] that it was slower to read other clinicians’ notes."
Respondents reported using a wide variety of systems, with 61 distinct EHR systems being identified. However, nine systems were used by 20 or more respondents and accounted for 79% (324) of all users responding to the survey. Of these nine, the Veterans Affairs’ Computer Patient Record System was associated with lowest amount of free time loss at less than 20 minutes per day.
"The loss of free time that our respondents reported was large and pervasive and could decrease access or increase the cost of care" Dr. McDonald wrote. "Policy makers should consider these time costs in future [EHR] mandates."
The authors reported no conflicts of interest.
The study was funded by the National Library of Medicine and the American College of Physicians. The authors reported no conflicts of interest.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Physicians may balk at using EHR systems because they consume rather than save time.
Major finding: EHR usage is accounting for 48 minutes of lost free time per day.
Data source: An analysis of 411 responses to a survey.
Disclosures: The study was funded by the National Library of Medicine and the American College of Physicians. The authors reported no conflicts of interest.
DEA expands drug take-back program to hospitals, clinics
Expanding on its successful National Prescription Drug Take-Back Program, the Drug Enforcement Administration will now allow hospitals and clinics with on-site pharmacies to collect excess prescription controlled substances for disposal on an ongoing basis.
The new regulations are designed to further minimize prescription drug abuse and diversion, according to the DEA. They were issued Sept. 8, and take effect Oct. 9.
Under the regulations, manufacturers, distributors, reverse distributors, retail pharmacies, registered narcotics treatment programs, and hospitals and clinics with an on-site pharmacy can operate disposal programs. Voluntary collection receptacles can be maintained at long-term care facilities as well.
Collected medications must be stored at registered locations in a securely locked, substantially constructed cabinet or a securely locked room with controlled access and may not be stored along with noncontrolled substances, according to the regulations.
Nearly 110 U.S. residents die every day from drug-related overdoses – half of those opioid related, according to the DEA.
"The road to prescription drug abuse is often through the medicine cabinet," Michael Botticelli, acting director of National Drug Control Policy, said during a press conference. "We know that 70% of people who initiate drug use get these drugs free from friends and family. These regulations create new, convenient, and environmentally friendly ways for people to get unneeded prescriptions out of their homes, preventing the possibility of misuse that so often leads to addiction."
The DEA’s National Prescription Drug Take-Back Program events began in September 2010. Eight national events have collected more than 4.1 million pounds of medication at 6,000 sites operated by law enforcement agents across all 50 states; the next one is scheduled for Sept. 27.
Expanding on its successful National Prescription Drug Take-Back Program, the Drug Enforcement Administration will now allow hospitals and clinics with on-site pharmacies to collect excess prescription controlled substances for disposal on an ongoing basis.
The new regulations are designed to further minimize prescription drug abuse and diversion, according to the DEA. They were issued Sept. 8, and take effect Oct. 9.
Under the regulations, manufacturers, distributors, reverse distributors, retail pharmacies, registered narcotics treatment programs, and hospitals and clinics with an on-site pharmacy can operate disposal programs. Voluntary collection receptacles can be maintained at long-term care facilities as well.
Collected medications must be stored at registered locations in a securely locked, substantially constructed cabinet or a securely locked room with controlled access and may not be stored along with noncontrolled substances, according to the regulations.
Nearly 110 U.S. residents die every day from drug-related overdoses – half of those opioid related, according to the DEA.
"The road to prescription drug abuse is often through the medicine cabinet," Michael Botticelli, acting director of National Drug Control Policy, said during a press conference. "We know that 70% of people who initiate drug use get these drugs free from friends and family. These regulations create new, convenient, and environmentally friendly ways for people to get unneeded prescriptions out of their homes, preventing the possibility of misuse that so often leads to addiction."
The DEA’s National Prescription Drug Take-Back Program events began in September 2010. Eight national events have collected more than 4.1 million pounds of medication at 6,000 sites operated by law enforcement agents across all 50 states; the next one is scheduled for Sept. 27.
Expanding on its successful National Prescription Drug Take-Back Program, the Drug Enforcement Administration will now allow hospitals and clinics with on-site pharmacies to collect excess prescription controlled substances for disposal on an ongoing basis.
The new regulations are designed to further minimize prescription drug abuse and diversion, according to the DEA. They were issued Sept. 8, and take effect Oct. 9.
Under the regulations, manufacturers, distributors, reverse distributors, retail pharmacies, registered narcotics treatment programs, and hospitals and clinics with an on-site pharmacy can operate disposal programs. Voluntary collection receptacles can be maintained at long-term care facilities as well.
Collected medications must be stored at registered locations in a securely locked, substantially constructed cabinet or a securely locked room with controlled access and may not be stored along with noncontrolled substances, according to the regulations.
Nearly 110 U.S. residents die every day from drug-related overdoses – half of those opioid related, according to the DEA.
"The road to prescription drug abuse is often through the medicine cabinet," Michael Botticelli, acting director of National Drug Control Policy, said during a press conference. "We know that 70% of people who initiate drug use get these drugs free from friends and family. These regulations create new, convenient, and environmentally friendly ways for people to get unneeded prescriptions out of their homes, preventing the possibility of misuse that so often leads to addiction."
The DEA’s National Prescription Drug Take-Back Program events began in September 2010. Eight national events have collected more than 4.1 million pounds of medication at 6,000 sites operated by law enforcement agents across all 50 states; the next one is scheduled for Sept. 27.
